Exploring Ototoxicity Associated with Capmatinib: Insights from a Real-World Data Analysis of the FDA Adverse Event Reporting System (FAERS) Database.

IF 3.2 2区医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Clinical Epidemiology Pub Date : 2025-06-03 eCollection Date: 2025-01-01 DOI:10.2147/CLEP.S528454

Yuhao Lin, Siqi Xu, Muling Deng, Yongli Cao, Jianming Ding, Tingting Lin

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引用次数: 0

Abstract

Background: Capmatinib was approved by the US Food and Drug Administration (FDA) in 2020 for the treatment of non-small cell lung cancer with MET exon 14 mutation (METex14). Real-world studies on the safety of Capmatinib are still lacking. The aim of this study was to explore the significant adverse drug reactions (ADRs) associated with Capmatinib through the FDA Adverse Event Reporting System (FAERS) database.

Methods: We employed the reported odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and the Empirical Bayes Geometric Mean (EBGM) as primary algorithms for the disproportionality analysis. Adverse events (AEs) were classified as adverse drug reactions (ADRs) solely upon fulfillment of criteria across all four algorithms.

Results: In our study, there were 1767 cases explicitly attributed to Capmatinib. A total of 38 ADRs in preferred terms (PTs) level in 14 system-organ categories (SOCs) were identified after filtering. Notably, unexpected SOC "Ear and labyrinth disorders" and PTs "hypoacusis" and "deafness" were identified, without being specified in the drug label.

Conclusion: Our study identified unexpected ADRs associated with Capmatinib, with a focus on ototoxicity-related events, underscoring the need for enhanced clinical monitoring and further investigation into the underlying mechanisms.

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探索与卡马替尼相关的耳毒性：来自FDA不良事件报告系统（FAERS）数据库的真实数据分析的见解。

背景：Capmatinib于2020年获得美国食品和药物管理局（FDA）批准，用于治疗MET外显子14突变（METex14）的非小细胞肺癌。关于卡马替尼安全性的实际研究仍然缺乏。本研究的目的是通过FDA不良事件报告系统（FAERS）数据库探讨与Capmatinib相关的重大药物不良反应（adr）。方法：采用报告优势比（ROR）、比例报告比（PRR）、贝叶斯置信传播神经网络（BCPNN）和经验贝叶斯几何平均（EBGM）作为歧化分析的主要算法。不良事件（ae）仅在满足所有四种算法的标准后被归类为药物不良反应（adr）。结果：在我们的研究中，有1767例病例明确归因于卡马替尼。筛选后，共确定了14个系统器官类别（soc）中优选术语（PTs）水平的38个adr。值得注意的是，意外的SOC“耳朵和迷路障碍”和PTs“听觉减退”和“耳聋”被识别出来，而药物标签中没有具体说明。结论：我们的研究确定了与Capmatinib相关的意外不良反应，重点是耳毒性相关事件，强调了加强临床监测和进一步研究潜在机制的必要性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Epidemiology Medicine-Epidemiology

CiteScore

6.30

自引率

5.10%

发文量

169

审稿时长

16 weeks

期刊介绍： Clinical Epidemiology is an international, peer reviewed, open access journal. Clinical Epidemiology focuses on the application of epidemiological principles and questions relating to patients and clinical care in terms of prevention, diagnosis, prognosis, and treatment. Clinical Epidemiology welcomes papers covering these topics in form of original research and systematic reviews. Clinical Epidemiology has a special interest in international electronic medical patient records and other routine health care data, especially as applied to safety of medical interventions, clinical utility of diagnostic procedures, understanding short- and long-term clinical course of diseases, clinical epidemiological and biostatistical methods, and systematic reviews. When considering submission of a paper utilizing publicly-available data, authors should ensure that such studies add significantly to the body of knowledge and that they use appropriate validated methods for identifying health outcomes. The journal has launched special series describing existing data sources for clinical epidemiology, international health care systems and validation studies of algorithms based on databases and registries.